Introduction: Transforming the Healthcare supply chain Yes, we should! (Ulrike Kreysa and Jan Denecker)... 2

Transcription

1 2011/2012

2 Table of Contents Introduction: Transforming the Healthcare supply chain Yes, we should! (Ulrike Kreysa and Jan Denecker) Argentina: Roche Argentina: Fighting counterfeit medicines using a traceability system based on GS1 Standards (Pablo Grimald) Australia: Health Corporate Network leverages the GS1 System for eprocurement success (David Melbourne) Brazil: The traceability system of medicines at Hospital Israelita Albert Einstein in Brazil (Nilson Gonçalves Malta) Canada: Enabling vaccine traceability in Canada using GS1 Standards (Dr. Monika Naus and Dr. Robert Van Exan) France: Just-in-time supply and automation at Strasbourg University Hospitals (Dr Raphaël Passemard and Caroline Mons) Germany: When the nursing staff become bar code fans (Tobias Schneider) Ireland: Bar coding on pharmaceutical packaging cuts costs and improves patient safety (Feargal Mc Groarty) Japan: Logistics management of pharmaceutical products with bar codes and RFID tags TBC Tokyo, Toho Pharmaceutical Co., Ltd. (Ryuta Suzuki) Korea: The role of Korea Pharmaceutical Information Service (KPIS) in patient safety (Dr. Jeong) Korea: Improvement of drug inventory management through GTIN and mobile system at the Seoul National University Hospital (You, Ock-Su and Kim, Kwi-Suk) Netherlands: St. Antonius Hospital: The traceability of implants (Menno Manschot) UK: Using GS1 Standards to combat counterfeiting and improve patient safety (Christoph Krähenbühl and Ian Haynes) USA: BJC HealthCare s Global Data Standardisation Initiative: Putting supply chain data to work (Thomas M. Stenger) /2012 GS1 Healthcare Reference Book

3 Inspiration, innovation and implementation Welcome to the third edition of the GS1 Healthcare Reference Book (Edition 2011/2012). From this edition, we hope that leaders and professionals will gain valuable information and inspiration on how leading Healthcare organisations have leveraged GS1 Standards to enable automatic identification and data capture (AIDC), master data management, electronic data interchange and traceability. Thirteen remarkable case studies provide a wealth of knowledge, creating opportunities for Healthcare supply chain stakeholders around the world. Beyond the boundaries of each country or region, all stakeholders are facing the same challenges today, to ensure the provision of safer patient care and to increase efficiency, and this should be done using global standards. We hope that these case studies will be an inspiration, triggering innovation and implementation in your organisation, country or region. Acknowledgements GS1 Healthcare would like to thank the following for contributing to this edition of the GS1 Healthcare Reference Book: Pablo Grimald, Roche Argentina (Argentina) Nilson Gonçalves Malta, Hospital Israelita Albert Einstein (Brazil) Ian Haynes, AstraZeneca (UK) Dr. Jeong, Korea Pharmaceutical Information Service Center (Korea) Christoph Krähenbühl, AstraZeneca (UK) Kwi-Suk Kim, Seoul National University Hospital (Korea) Menno Manschot, St. Antonius Hospital (Netherlands) Feargal Mc Groarty, St. James s Hospital Dublin (Ireland) David Melbourne, Health Corporate Network (Australia) Caroline Mons, Strasbourg University Hospitals (France) Dr. Monika Naus, British Columbia Centre for Disease Control (Canada) Ock-Su You, Seoul National University Hospital (Korea) Dr Raphaël Passemard, Strasbourg University Hospitals (France) Tobias Schneider, Heidelberg University Hospital (Germany) Thomas M. Stenger, BJC HealthCare (USA) Ryuta Suzuki, TOHO Pharmaceutical Co., Ltd (Japan) Dr. Robert Van Exan, Sanofi Pasteur (Canada) In addition, we would like to thank the following GS1 Member Organisations for facilitating this process: GS1 Argentina (contact: Gabriel Melchior - gmelchior@gs1.org.ar) GS1 Australia (contact: Tania Snioch tsnioch@gs1au.org) GS1 Brasil (contact: Wilson José da Cruz Silva wilson.cruz@gs1br.org) GS1 Canada (contact: Alicia Duval alicia.duval@gs1ca.org) GS1 France (contact: Valérie Marchand valerie.marchand@gs1.fr) GS1 Germany (contact: Bettina Bartz bartz@gs1-germany.de) GS1 Ireland (contact: Jim Bracken - jim.bracken@gs1ie.org) GS1 Japan (contacts : Michio Hamano hamano@dsri.jp and Yasuo Kurosawa kurosawa@dsri.jp) GS1 Korea (contact: Howon Hoya Kim - hwkim@korcham.net) GS1 Netherlands (contact: Hans Lunenborg hans.lunenborg@gs1.nl) GS1 UK (contact: Roger Lamb roger.lamb@gs1uk.org) GS1 US (contacts: Ed Miles emiles@gs1us.org and Annette Pomponio apomponio@gs1us.org) 2011/2012 GS1 Healthcare Reference Book 1

4 Transforming the Healthcare supply chain Yes, we should! From pharma security to unique device identification By Ulrike Kreysa, GS1 Global Office and Jan Denecker, GS1 Global Office I have a dream (Martin Luther King Jr.) We have a dream that one day medicines will be bar coded and scanned at every step in the dispensing process, to avoid medication errors. We have a dream that one day medicines will be traceable and verified at the point of dispensing, to fight counterfeit medicines. We have a dream that one day medical devices can automatically and uniquely be identified, to enable effective and efficient product recalls and adverse event reporting. We have a dream that one day Healthcare will automate all its supply chain process, to increase efficiency and save costs. We have a dream that one day all Healthcare stakeholders will recognise that Healthcare supply chains cross borders and that a global framework is needed. And we have more dreams to turn into reality. We are GS1 Healthcare a global community of Healthcare supply chain stakeholders advancing global standards to transform the Healthcare supply chain, improving patient safety and increasing efficiency. Representing the global Healthcare supply chain, from Pfizer and Johnson & Johnson to the Mayo Clinic and the Hong Kong Hospital Authority /2012 GS1 Healthcare Reference Book

5 Never put off to tomorrow what you can do today. (Thomas Jefferson) Over the last 6 years, many volunteers from around the world have invested their time and expertise in the development and enhancement of GS1 Global Standards to identify and automatically capture information regarding products, assets, services and locations in the Healthcare sector, and to share supply chain information between supply chain partners. Progress has been made in the adoption and implementation of those standards, but GS1 Healthcare urges all Healthcare supply chain stakeholders worldwide to start using the standards in all related supply chain processes, from production to distribution to the point-of-care there is great benefit for everybody. Change before you have to. (Jack Welch) The best way to predict the future is to create it. (Peter Drucker) GS1 Global Standards ensure compatibility and interoperability of supply chain solutions, not only within your organisation, but also in your country and across borders. Without them, how unique is the identification of a product or location? How can purchase orders, dispatch advices and invoices be seamlessly exchanged? How can accurate product information be more effectively shared? Where do traceability systems get reliable physical event data? Over 100 GS1 Member Organisations worldwide are ready to support you in the implementation of GS1 Global Standards, today. Governments worldwide are taking action to address patient safety concerns and the associated rapidly escalating Healthcare costs. Important policy changes are on the way and some of them will have a direct impact on the Healthcare supply chain. The world hates change, yet it is the only thing that has brought progress. (Charles Kettering) 2011/2012 GS1 Healthcare Reference Book 3

6 Roche Argentina: Fighting counterfeit medicines using a traceability system based on GS1 Standards Abs t r ac t In order to fight the proliferation of counterfeit medicines, Roche Argentina implemented a traceability system in March The system, based on GS1 Standards, allows the identification of the destination of each unit, and does likewise for the whole distribution chain. Moreover, the patient can validate the legitimacy of the medicine before consuming it (i.e. that the medicine has been released to the market by the corresponding manufacturer and does not have any reported adverse event). By Pablo Grimald, Roche Argentina The problem: Counterfeit medicines Counterfeit medicines are those deliberately and fraudulently processed so that they do not reflect their real content or real source (WHO). Counterfeit medicines comprehend: Absence of Active Ingredient Different Active Ingredient from the declared one Different quantity of Active Ingredient declared Counterfeiting of packaging Adulteration of packaging Inappropriate storage conditions for the product (e.g. in the case of stolen or smuggled medicines) Figure 1 reflects the consequences caused by counterfeit medicines. Currently, there is a local trend for counterfeiters to focus on high cost medicines due to: Management of reduced volumes which imply high profits Low investment is required Easiness to hide The consequences from consumption of counterfeit medicines vary from a lack of therapeutic action to more considerable damage, which may include the risk of death. Most of these medicines are for Oncology treatment, and in many cases provide the only chance of life expectancy to these patients with this serious pathology. Figure 1: Counterfeit Medicines Theft Smuggling Counterfeiting Adulteration Storage conditions and irregular transportation High risk of harm to patient Lack of medical treatment and high risk of harm to patient Manufacturer: economic loss and image damage /2012 GS1 Healthcare Reference Book

7 Roche Argentina: Fighting counterfeit medicines using a traceability system based on GS1 Standards Project objectives This situation led to the design of a process, which allows the verification of the source of the product before its consumption, avoiding the proliferation of counterfeit medicines, and in case a counterfeit one is found, it contributes to its clear identification. For such reason, the traceability system has been implemented. It means that each product unit is uniquely identified, in order to track it in the value chain. Application environment At the beginning of the project, the first step was to investigate the local and global records on medicine traceability, and these were the findings: Previous experiences The existing traceability cases showed: In Argentina: important wholesalers who commercialise products for special treatments (Oncology, Aids, Arthritis, etc.) have implemented traceability, but with proprietary coding and identification, not compatible with each other. Latin America: implementation of proprietary coding and identification systems at manufacturers was noticed in some countries. Experiences in the world: only pilot experiences existed with different identification technologies (RFID and GS1 DataMatrix). Market standard In Argentina: absence of national legislation and existence of traceability systems implemented by wholesalers without a coding, identification or communications standard. In the World: in some countries, regulations are very ambiguous, and did not detail neither coding nor technology for code carrier. Distribution chain Figure 2 shows a basic diagram of commercialisation of these types of product in Argentina. There are transactions among wholesalers (Step 2). The absence of legislation that demands the distribution chain to trace units is the obstacle to implementation of steps 2 and 3. Figure 2: Distribution Chain Step 1 Manufacturer Wholesalers Step 2 Pharmacies and Healthcare institutions Step 3 Patient Step 4 Consumption About Roche Headquartered in Basel, Switzerland, Roche is a leader in research-focused Healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche s personalised Healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in patients health and quality of life. Roche has over 80,000 employees worldwide and holds several R&D cooperation agreements and alliances. Logistics Many of the medicines, which have suffered illicit events, are imported as finished products. Roche s production plants for these types of product are few, specialised and are high volume and highly automated lines. The implementation of identification and traceability at source only for Argentina (GS1 DataMatrix or RFID printing devices) is complex. Roche, as well as more than 70% of the local pharmaceutical industry, have an internal logistics diagram, which includes three actors, as shown in Figure 3, where the main actors are: Manufacturer: product owner and responsible to authorities. Distributor: responsible for manufacturer inventory safekeeping. Manages orders, invoices on behalf of the manufacturer, and in some cases, collects payments. Most distributors delegate the warehouse management, picking, packing and transport to a logistics operator. Logistics Operator: manages warehouses, picking, packing and transport. Developed solution The solution was developed and implemented with the following characteristics: Market scope Due to the absence of national legislation, and taking into account the impossibility to have an influence on the whole distribution chain, the implementation was done in steps. 2011/2012 GS1 Healthcare Reference Book 5

8 Roche Argentina: Fighting counterfeit medicines using a traceability system based on GS1 Standards Step 1: Recording sales transactions from the manufacturer to the first connecting link of the distribution chain (Step 1, in Figure 2). Additionally the patient can verify if the product contains a valid serial number from the manufacturer, or identify any events that could harm its quality (Step 4, Figure 2). Step 2: a data processing solution is implemented for the distribution chain that allows them to obtain traceability, with integration to the system of the laboratories. Taking into account that this is the oldest technology, from the ones mentioned, and it is believed not to be the most efficient in operative terms for large volumes, a second step will be the migration of the carrier to one of the other technologies available. Figure 6 shows the tag, which contains the following information: Coding and data carriers Considering the pilot tests already taking place in the world, the use of GS1 Standards was defined for coding and data carriers. This will probably facilitate the adoption of this solution or similar ones using standards, both for the market and for national regulators. The data carrier is the means that will contain the traceability data. Considering the available technologies (GS1 DataBar, GS1-128, GS1 DataMatrix and RFID) we adopted GS1-128 for the following reasons: It is a technology used by all Wholesalers and Pharmacies, which means fewer barriers for the implementation of traceability in the Distribution Chain. Traceability solutions currently implemented by local Wholesalers are based on this technology. As most products, vulnerable to counterfeiting in the Argentine market, are imported as finished products, and considering that the production plants do not have the infrastructure to handle GS1 DataMatrix and/or RFID, this technology allows us to add a high security tag on finished products, with very low complexity. GTIN Serial number (8) Hidden code for validation (scratch-off). This is an additional safety measure to the GS1 Standard, and it is not found in the GS1-128 code, only in Arabic numerals. The tag contains the following safety measures: Logical Measures of Safety Random 8 digit serial number (100 million combinations for each GTIN) Random 6 digit alphanumeric scratch-off code (more than 2 billion combinations for each GTIN) Figure 3: Logistics Internal Logistics Environment client Manufacturer Distributor Logistics operator The three actors have independent data processing platforms, which are linked by interfaces that synchronise the information (Inventories, Sales, Accounts Receivable, etc.). Nobody was, at the time of implementation, prepared to handle traceability by unit /2012 GS1 Healthcare Reference Book

9 Roche Argentina: Fighting counterfeit medicines using a traceability system based on GS1 Standards Physical Measures of Safety in the tag: Destroyable tag when taken off, leaving proof on the container Visible safety measures for the user (micro texts, special inks containing cholesterine, scratch-off, etc.) Safety measures to be verified only by the Manufacturer (UV inks, hidden codes, etc.) Characteristics of the system Functions of the system: Its functions are (Figure 5): Identification: allows the identification of each unit with a unique serial number. The system generates random unrepeated serial numbers. The products are identified and a relation between serial number and batch is made. It also allows the addition of serial numbers (group of serial numbers in one tag, for example for managing pallets). Traceability: this module is responsible of managing the serial numbers in the inventory, permitting: Entry of serial numbers, transfers among actors (manufacturer, distributor and logistics operator) Control and adjustments of serial numbers in warehouse Registration of sales transactions (sales and returns) Validation: informs both the distribution chain and the patient of the status to commercialise or consume a serial numbered item. Consults and validations may be done on the web or by telephone to a toll free number. In the future, the validation will be able to be done by text messaging through mobile phones. It also generates different types of alert, for example if more than one patient validates a serial number. Serial number: Status diagram The serial numbers may have various functions in the system. Each status limits the type of transaction that may be done with it. Figure 6 shows the status generated by each transaction in a normal sales flow. At the lower part, it also shows the permitted transaction for each status. Figure 5: Traceability systems, Main fonctions Identification Serialisation Assign serial number Identification of units Capturing serial numbers Traceability Status registration Receipt Stock management Shipping How information is shared Validation Verification of authenticity Distribution chain Patient validation Alarm Due to the fact that none of the actors of the internal logistics environment (manufacturer, distributor and logistics operator) have a traceability system implemented, the implementation of a unique and external system was defined, which everyone can access and operate (Figure 7). The advantages are: Less interfaces between the systems of the actors, decreasing complexity. On-line updating of the serial number status due to the fact that there are no interfaces between systems. Figure 6: Serial Number Conditions Usual transaction in a sale flow Serial Number Generation Tag Printing Product Tagging Product Sale to Client Validation by patient Generated status Generated Entered Assigned Sold Validated Permitted transaction per status Sell from manufacturer r r a r r Commercialize in the market r r r a r Patient usage r r r a r 2011/2012 GS1 Healthcare Reference Book 7

10 Roche Argentina: Fighting counterfeit medicines using a traceability system based on GS1 Standards Figure 7: Internal logistics and distribution channels Internal logistics Environment Distribution channel Hospitals Institutions Wholesalers Manufacturer Distributor Logistics Operator Pharmacies Patients Unique and centralised information: everyone accesses the same information at the same time. Increased safety: considering that the serial numbers are random, and the fact that the serial numbers are found in a unique data repository, decreases the possibility of information extraction. In step 2, when the distribution channel is included, the communication will be permitted instantly. The system is on the web and may be accessed through any Internet connection. System development and operation diagram It was decided that the system should be developed by a technology provider with experience in traceability, Farmatrack, from the Fobesa Group was chosen. In order to have continuous improvements and updates, it was decided to choose the developer for the operation and maintenance of the system; who will provide the traceability service. Therefore, the Farmatrack System has the following characteristics: Investment on development, hardware and communication is done by the provider Responsibility for the systems hosting Service based on a fee for each serial number used by manufacturer The service can be provided to other manufacturers, distributors, logistics operators, wholesalers and pharmacies. The adoption of this tool, by other manufacturers and other actors of the distribution chain, is a key factor for the long-term sustainability of the project, due to the fact that the bases are established to: Contribute to establish a standard for the local market. Increase dissemination and knowledge about the tool. Incentive for use, so Healthcare professionals and patients become used to validating the products before providing or consuming them. Implementation Impact on the operation Identification The impact on the identification of the product is summarised in the following: Cost of tags Operation of tags /2012 GS1 Healthcare Reference Book

11 Roche Argentina: Fighting counterfeit medicines using a traceability system based on GS1 Standards Warehouses It must be guaranteed that all products leave the warehouse are scanned [read], without crossing units (serial numbers) among orders. During the dispatch process, the serial number reading takes place at the moment of packing, which guarantees that the serial numbers packed are exactly the ones read. The system controls the consistency of batches and quantities of each order, making possible the dispatch of the order only if it is complete and coincides with what is required. Traceability has an impact on the logistics operation when time is added for picking and inventory management, which is translated into costs. Validation The validation on the web has no cost; while through the contact centre there are communication (free call) and operation costs for the contact centre. Product selection, sequencing and batch considerations The products traced were chosen in relation to the risk of being counterfeited. Products that have been counterfeited the most were chosen as the highest risk, considering their sales volume and billing amounts. For the manufacturer: Less counterfeit units, which implies: Greater demand for original units, more sales Lower risk of recall Image improvement, if there is more consumption of original units there is provable therapeutic action. Recall cost reduction; by identifying only counterfeit units for recall versus the recall of complete batches. Next steps Today, two other multinational manufacturers are implementing this solution in Argentina, which will be useful for consolidating the concept in the market. There are two more local companies studying its adoption. On the other hand, there are several projects, both legislative and from the Argentine Ministry of Health, to regulate and extend the implementation of traceability. The projects are mostly compatible with what we have implemented. Based on these variables, SKUs were taken as a priority and were included in an implementation chronogram, incorporating a new SKU every 15 days. The criteria is tracing only complete batches (not partial ones). Once the SKU begins to be traced, all future batches will be traced. We have already traced all the products that had suffered adulteration, plus some that were likely of suffering it, with a total of 12 SKUs, which represent more than 80% of the local pharmaceutical sales. Communication plan Dissemination is a key factor for success. We have designed a communication plan with the objective of communicating about the new system and motivating patients and health professionals to use it. The plan, developed in 2010, had various actions targeted inside and outside the company. Expected benefits For the patient and the society: Product legitimacy validation prior to consumption Lower risk of harm from the use of counterfeit medicines Access to expected therapy About the author Farmatrack is developing a new version of the software, containing several improvements, mainly with the objective to Pablo Grimald, Commercial Logistics Manager, facilitate the incorporation of new laboratories. Moreover, step 2 Pharma Division in Roche Argentina is being defined to provide a solution for the rest of the chain. During Pablo this Grimald year, we is responsible will disseminate for Sales data, Administration, of the use of validation, Distribution together and Demand with the other Planning. new He laboratories has more than and GS1 Argentina. 20 years experience in pharmaceutical market and he has leaded several projects, providing his know-how in projects aimed at harmonizing processes and systems among Latin America Region. Pablo has a degree as Engineer in Information Systems conferred by National Technological University (UTN), and is MBA graduated from CEMA University (UCEMA), Argentina. 2011/2012 GS1 Healthcare Reference Book 9

12 Health Corporate Network leverages the GS1 System for eprocurement success Abstract Health Corporate Network (HCN), an organisation that delivers shared services, including supply, to the West Australian Department of Health identified an increase in the volume of paper procurement transactions being processed, placing a significant burden on staff. A decision was made to implement eprocurement using the NEHTA eprocurement Solution to automate some of the manual processing. The basis for NEHTA s eprocurement Solution is GS1 s emessaging Standard, GS1 XML combined with the Australian Standard (AS) 5023, which defines message data set and business rules for Healthcare. HCN was conscious that eprocurement processes must be based on accurate and complete product data, and so made the decision to mandate population of the National Product Catalogue (NPC) as a pre-requisite for implementing eprocurement with any supplier. A range of benefits have been realised since eprocurement implementation commenced and these will increase as the number of suppliers involved grows. By David Melbourne, Health Corporate Network Background WA Health is the state of Western Australia s public health system, providing services to around 2.3 million people across an area of almost 2.5 million square kilometres (approximately five times the size of Texas) from the capital city Perth, to rural centres and some of Australia s most remote Outback areas. Facilities run by WA Health include public hospitals, community and mental health services, drug and alcohol prevention and treatment services, dental health services and Aboriginal health services. In 2009, WA Health handled more than 837,000 emergency department visits, completed more than 75,000 elective surgery cases, delivered 22,330 babies and performed more than 91,000 breast cancer screens. Health Corporate Network (HCN) is a shared-service entity that provides Human Resources, Supply, Finance and Business Systems services to WA Health. HCN s primary role in the WA Health community is to help clinical staff to provide the best service they can to the patient whether through supply chain efficiencies or improved business and administration processes. Its strategy is aligned with the Federal Government s National ehealth Strategy which is being implemented by the National ehealth Transition Authority (NEHTA). The Strategy outlines four priorities: Urgently develop the essential foundations required to enable ehealth Coordinate the progression of the priority ehealth solutions and processes Accelerate the adoption of ehealth Lead the progression of ehealth in Australia Each of the state and territory health jurisdictions have (by their presence on the board of NEHTA) committed to driving and implementation of NEHTA s strategy. Amongst the foundation work areas identified by NEHTA was supply chain. This work effort was one of the first commenced, given it was seen as a key focus area that would drive efficiency, savings and improved patient safety in Australia s public hospital sector. The supply chain work effort has three areas: Creation of a National Product Catalogue (NPC) Development and roll out of an eprocurement / emessaging solution Documentation of business intelligence tools and references eprocurement and the Australian Public Health Sector Across all Australian states and territories procurement processes have been predominantly manual and lacked standards. In 2007 NEHTA announced its selection of GS1 XML as the eprocurement format and structure that would form the backbone of its eprocurement solution. The data set to be transacted within the GS1 XML structure has been specified using Australian Standard (AS) Combined, the use of GS1 XML and AS 5023 provide a strongly standards-based solution, laying the foundation for development of long-term electronic transaction capabilities by all of Australia s states and territories /2012 GS1 Healthcare Reference Book

13 Health Corporate Network leverages the GS1 System for eprocurement success Figure 1: The NEHTA Federated HUB Model Wa Health Buyer Supplier HUB Provider Internal HUB The foundation of the eprocurement solution is four transactional messages, the Purchase Order (incorporating the Purchase Order Change), Purchase Order Response, Despatch Advice (also called Advanced Shipping Notice ASN), and Invoice. Also within the NEHTA eprocurement solution is the specification that EDI Service Providers (HUBs) organisations that provide EDI messaging services to suppliers and buyers must operate in a federated hub structure, refer to Figure 1. This means that a supplier and buyer can choose to engage their HUBs based on their own business partner selection criteria and own commercial negotiations. If the supplier and buyer then choose to exchange messages electronically and the messages meet the NEHTA specifications, there is no expectation that the supplier or buyer will pay each other s HUBs any fees, nor will either trading partner s HUB pay for the interconnection fees (connectivity and movement of messages) between the HUBs. 2011/2012 GS1 Healthcare Reference Book eprocurement in Western Australia After HCN s formation in 2006, it was identified that there was an increasing trend in the volume of paper transactions being processed by WA Health and this was placing a significant burden on procurement staff. HCN was processing up to 1500 purchase order lines and 3500 invoice lines daily for WA Health. To efficiently and effectively manage all transactions it was identified that HCN would need to change existing processes. In 2008 a business improvement decision was made to implement eprocurement, in line with NEHTA s eprocurement Solution, to automate as much of the manual processing as possible. A further driver was government budget cuts and subsequent organisational restructuring. Automation was seen as a way to free up employees to focus on value-added tasks. With electronic purchase orders, invoices and other documents, the accounts payable department would have less manual work. HCN was the first health jurisdiction to move down this path. 11

14 Health Corporate Network leverages the GS1 System for eprocurement success Figure 2: NPC Data Flows Hospital Supplier 1 Hub A Hub B Hospital HUB working for a Data Recipient HUB working for a Data Supplier Supplier 2 Health Department National Product Catalogue (GS1net) Supplier 3 Recipient Supplier Supplier 4 Private Sector Wholesaler The importance of accurate master data To implement eprocurement successfully HCN realised that they had to ensure both their own data and their suppliers data was 100 per cent accurate and kept up to date. It was very clear early in the eprocurement implementation process that using inaccurate data in electronic messages simply added to the work effort of staff. eprocurement without accurate master data causes more work than paper processing. To achieve synchronised and accurate data HCN turned to the National Product Catalogue (NPC), which has been developed as the single source of item master data for Australian health organisations seeking to purchase medicines, medical devices and other necessary Healthcare items. Figure 2 details the NPC data flow process. The NPC has been endorsed by all state, territory and federal health departments in Australia as a single repository of product, pricing and Healthcare data and is hosted by GS1 Australia on the GS1net data synchronisation platform. Used by an ever increasing number of suppliers, this solution contains built-in data validation checks that aim to prevent suppliers loading incomplete or inaccurate records. HCN has mandated that suppliers must have published their data on the NPC as a pre-requisite to implementing eprocurement. HCN tells all suppliers that if they do not have their information on the NPC they cannot provide their trading partners, including HCN, validated and complete data. Secondly they cannot maintain synchronised data. That means HCN cannot engage in eprocurement with them. By requiring suppliers to populate the NPC with their data before implementing emessaging, HCN has put in place a contingency to minimise the risk of incorrect data and therefore increased work effort. Definition and documentation of business process: The Message Implementation Guideline For HCN, the next step towards eprocurement implementation with suppliers was to document their business rules, requirements and processes, including data set. The output of this process is called a Message Implementation Guideline (MIG). HCN worked closely with NEHTA throughout this process. The MIG is an essential part of eprocurement documentation, it provides a set of requirements for all trading partners providing explanations of which GS1 XML messages are used, and how a given jurisdiction s software applications and business processes work. The HCN MIG provides suppliers a guideline for electronic trading using the NEHTA Specifications for the Purchase Order, Purchase Order Response and Invoice messages. HCN intend to move to a full complement of messages, with the Despatch Advice currently being developed /2012 GS1 Healthcare Reference Book

15 Health Corporate Network leverages the GS1 System for eprocurement success Figure 3: The HCN eprocurement Process Overview Invoice Purchase Order Response Purchase Order Supplier Warehouse Packaging HCN Demand Shipping Receiving Hospitals Wards WA is the first Australian jurisdiction to have a MIG and this has ensured that it is simpler for HCN to communicate to their suppliers exactly what is required when implementing eprocurement. This MIG has been subject to self assessment by HCN using the NEHTA Compliance, Conformance and Accreditation (CCA) scheme. As detailed in Figure 4, HCN have decided to function as their own HUB giving them the flexibility to manage their messaging flows and simply and easily connect with the HUBs selected by their trading partners and move data into their ERP System. Benefits seen since implementation are: With the development of the MIG, HCN have mapped their business process against best-practice specifications. Leveraging off the successful HCN MIG outcome, South Australia and the Australian Capital Territory (ACT) have also successfully completed the NEHTA compliance process. NEHTA will continue this work effort with all health jurisdictions and the private health sector Australia-wide. All business processes across jurisdictions are to be documented in a single national reference which means suppliers will have a single eprocurement implementation guideline for Australian public Healthcare. Figure 3 details the HCN eprocurement process, highlighting the collaborative and cyclical relationship between the parties involved. Current HCN status Since 2008 HCN has commenced eprocurement implementation with a number of companies including Baxter Healthcare, B.Braun Australia, Bunzl Australasia and KCI Medical. Discussions are continuing with a number of other suppliers including Western Biomedical, Becton Dickinson and Medical Sales and Service. More accurate identification of ordered products due to the use of GTINs. There is no confusion as to what pack size, colour, etc is being ordered. When using internal part numbers such confusion is common. With prompt receival of a purchase order response, problems can be resolved more quickly. For example, if an item is out of stock, this can subsequently be sourced from an alternative supplier. Prompt notification of any price discrepancies means issues can be identified and addressed immediately. When electronic invoice and purchase order details are matched, the invoice is validated immediately. This means no intervention is required by Accounts Payable staff, decreasing workload. Payments are usually made more quickly. When paper invoices are used, these can often be mislaid or not sent to the Accounts Payable team, which delays payment. HCN is continually working collaboratively with suppliers to help them become ready to be involved in eprocurement implementation with purchase order, purchase order response 2011/2012 GS1 Healthcare Reference Book 13

16 Health Corporate Network leverages the GS1 System for eprocurement success Figure 4: HCN Systems and Data Flow Product master data changes Product master data update NPC eprocurement with direct link to HCN HUB Oracle 11i Supplier eprocurement for supplier using their own HUB Supplier HUB Health Corporate Network and invoice messages. Suppliers must have published data to the NPC to be considered, but also have the implementation of eprocurement in their own business objectives. For suppliers who have published their product data to the NPC but are not ready to move down the eprocurement path, HCN have started providing GTIN and Global Location Number (GLN) information on their paper purchase orders, thus creating familiarity and awareness of their reliance of data from the NPC. Most importantly, these references ensure even suppliers processing orders manually know exactly which items and levels of packaging are being ordered by HCN and the correct locations to which the goods should be shipped. It further enhances the message that if suppliers publish their data to the NPC, HCN will access it and incorporate it into their procurement systems. About the author David Melbourne, Senior Business Analyst, Health Corporate Network David Melbourne is currently employed as a Business Analyst by Health Corporate Network and co-ordinates their ecommerce project. He started his working life as a Pharmacist in South Australia before heading to Perth in In 2006 he was seconded to assist with data mapping for a Pharmacy project which become a career changing move as he is now working closely with NEHTA and GS1 Australia to implement the National Product Catalogue and eprocurement for WA Health. HCN s ultimate aim is to send and receive as many procurement transactions electronically as possible. Current targets are to have up to 15 suppliers live with purchase order, purchase order response and invoice messages by the end of Global Standards and National Healthcare specifications are crucial to this. If everyone is talking the same language, development of solutions for the Australian ehealth Supply Chain sector becomes extremely efficient /2012 GS1 Healthcare Reference Book

17 The traceability system of medicines at Hospital Israelita Albert Einstein in Brazil Abs t r ac t Focusing on patient safety, Albert Einstein Hospital (HIAE) has evaluated the entire cycle of drugs use and established three specific steps in the process where to implement electronic safety blocks: ordering, dispensing and administration. HIAE initiated the intra-hospital traceability project to monitor the receipt, distribution, dispensing, and administering of drugs. In a first phase, drugs were re-labeled in-house, and in a second phase, a supplier took up the challenge to print a bar code on the label of each unit of electrolyte ampoules in their production line. This allowed to include variable data such as batch number and expiry date. More suppliers were then invited to adopt the GS1 DataMatrix bar code. As a result, HIAE could reduce adverse drug events on dispensation and save costs by replacing in-house re-labeled drugs by industry two-dimensional codes ready identified labels. By Nilson Gonçalves Malta, Hospital Israelita Albert Einstein Introduction According to studies by the American Hospital Association and another led by David Philips, both demonstrated by the IOM in its report To Err Is Human, 1999, each year 44,000 to 98,000 people die from medical errors and about 7,000 only by medication errors, inside or outside of hospitals. Additionally, it has been cited, that 2% of hospital admissions were subject to preventable adverse drug events, increasing the length of stay of 4.6 days with an additional cost of $ 4,700 per admission 1. In statistics from the Centers for Disease Control and Prevention (CDC), this same report concluded that more people die from medical errors than from automobile accidents. Although more than 10 years have passed, these figures are alarming and makes us consider the quality of service nationwide. The costs of errors in estimation followed between 17 and 29 billion U.S. dollars annually. Medication errors in the most recent report of the IOM relied, in 2006, with an annual estimate of 400,000 adverse drug events, with consequent cost of 3.5 billion dollars annually 2. In a study regarding the possible sources of medication errors, the ASHP, the American Association of Health System Pharmacists reported that 39% of errors occur at the time of prescription, 12% in transcription of medical orders, 11% in dispensing and 38% in medication administration 3. While 1 Kohn LT, Corrigan JM, Donaldson MS, eds. To Err is Human: building a safer health system. Washington, DC. National Academy Press; Aspden P et al. Preventing Medication Errors: Quality Chasm Series. Washington, DC. National Academy Press; ASHP Report ASHP Leadership Conference on Pharmacy Practice Management. Executive Summary: Looking to the future: Leading and managing change. Am J Health-Syst Pharm 2004; 61(10): these data are not specifically the national reality, are of vital importance as parameters for the improvements. The data presented above are relatively recent, but the problem goes back much further. Already in the 1950s and 1960s, the Unit Dose Drug Delivery System (UDDDS) was developed in the USA as a means to reduce the alarming numbers of medication errors at that time. The UDDDS is a system through which the pharmacy dispenses the medication in the form which is ready for use, according to the dose ordered by the doctor, without the need of further manipulation 4. Despite being recognized as the safest method of dispensing developed so far, the indicators still show that we have many weak points in the process and they deserve our full attention. But now, if we adopt the UDDDS as the best method of dispensing, what else do we need to accomplish? 4 American Society of Health-System Pharmacists [ASHP]. Best Practices for Health-System Pharmacy. Positions and Practice Standards of ASHP Bethesda, md: ASHP; 1998: p.134-5, /2012 GS1 Healthcare Reference Book 15

18 The traceability system of medicines at Hospital Israelita Albert Einstein in Brazil Patient safety at Hospital Israelita Albert Einstein (HIAE) Focused on patient safety, we have evaluated the entire cycle of drugs use and decided to focus our actions on ordering, dispensing and administration. With the direct involvement of Pharmacy, we implemented an electronic ordering system and a safer logistics process from receipt of the products to their disposal. These actions were aligned with the culture of quality and safety in HIAE which, even in the late 1990s, was seeking unprecedented certification from the Joint Commission Accreditation on Healthcare Organizations (JCAHO) outside the United States. The project allowed us to fulfill the Joint Commission s standard regarding the traceability of medicines. Joint Commission Accreditation on Healthcare Organizations Standard MM (MMU.3.3 of Joint Commission International) The [organization] follows a process to retrieve recalled or discontinued medications. The concept of quality of a Unit Dose System is unquestionable, but we see weak spots. With so many technological advances in our society, it is vital to take all reasonable and available means to safeguard the lives we serve daily. Our actions have been confirmed and reinforced with the publication of the IOM, which recommends the computerization and automation as means to prevent errors and adverse effects 5, in summary, a mechanism widely available and an efficient source of security. Fig. 2 Re-labeled ampoules To circumvent the problem and meet this demand, the alternative adopted was in re-labeling (re-identification) of medicines in all types of presentation and dosage forms, printing a bar code containing the product data, batch number and possibly expiry date, as well as that information in human readable format. For ampoules and vials it was a cumbersome solution (Fig. 2), but the situation became even more critical when dealing specifically with drugs in solid dosage forms (e.g. tablets, capsules, etc.) 6. To have this information on each unit of consumption, we had to cut original blister packs and individually overwrap each unit. To facilitate this process, HIAE invested in a table top machine for unit dose repackaging (Fig. 3). In the Brazilian market, the sale of drugs in bulk is practically nonexistent, which makes this activity more costly and creates too much waste, like cartridges, blister packs and package inserts. For this practice, later, with the publication of RDC 67/2007 ANVISA (Resolution of Directive College) 7, in the repackaging process through table top machines, the validity of the drug should be reduced to 25% of its original remaining time. This situation remains until today. In 2005, for the attendance of 460 beds, emergency care and two outpatient units (Paraisópolis Alphaville), HIAE repackaged approximately 80,000 oral solids and relabeled about 250,000 ampoules or vials per month. The traceability project The first step To improve patient safety, HIAE initiated the intra-hospital traceability project,which had the purpose of monitoring the reception, distribution, dispensing, and administration of medication, and maintaining control over batch and expiry date of medicines in these processes. Until then it was not possible to perform traceability because the drugs supplied by the manufacturers did not possess the minimum requirements for such control. Not all suppliers provided properly identified Fig. 1 EAN 13 code packages. Even if there was a bar code, it reported only what product it was (EAN13 code Fig. 1), and usually in their secondary packaging. When it comes to dispensing hospital, it is imperative that full identification is carried out on primary packaging. 5 Institute of Medicine. Crossing the Quality Chasm. A New Health System for the 21st Century. Washington, DC. National Academy Press; Cina J, et al. Implementing a bar code repackaging center: a case study of the process from the department of pharmacy services Brigham & Women s Hospital in Boston. Pharm Purchasing Products 2004; 1: BRASIL. Agência Nacional de Vigilância Sanitária. RDC nº67, de 1º de outubro de Regulamento Técnico sobre Boas Práticas de Manipulação de Preparações Magistrais e Oficinais para Uso Humano em farmácias. Diário Oficial da República Federativa do Brasil, Poder Executivo, Brasilia, DF, 8 de outubro de 2007, Seção 1. Available at < rdc_anexo.pdf> accessed on February 3, /2012 GS1 Healthcare Reference Book

19 Risks The activity of re-labeling is a critical step as it adds cost - namely the high cost of manpower - and risk - the risk of having of incomplete or inaccurate information. To prevent these errors, a policy and post-labeling quality control need to be developed 8. We can also see errors when receiving medications. Right now, with lot control in the internal distribution of products, the lot information and expiry date should be typed into the system. With this, we run up against the risk of copy error, compromising the ability of traceability of data over the period of medication use. Furthermore, we have to pay attention to the printing quality of labels, because faded codes can not be read and the whole chain is compromised. Therefore, it is essential to have an effective program of preventive maintenance on printers, labels and acquisition of appropriate print film, so that it will not fade out during handling or with liquids used in aseptic processes. The ideal solution Through our participation in the GS1 Healthcare Brasil user group, we identified a supplier that accepted the challenge of applying the two-dimensional GS1 RSS-14 code (currently called DataBar Fig. 4) on the label of each unit of electrolyte ampoules in their production line. In this format of higher capacity, you can enter variable data such as batch and expiry date on their information content. Later in 2008, new partners have joined the programme and followed the international guidelines that required the Fig. 4 - GS1 DataBar use of GS1 DataMatrix code (Figs. 5 and Stacked Omnidirectional 6). With this new two-dimensional code with variable content, the re-labeling of all products was no longer needed, and a safer receiving process was established. Upon reading the code, the system automatically imports the data from batch and expiry date, thus eliminating the possibility of error in the inventory Fig. 5 GS1 DataMatrix system data record. In a survey on the current status of hospital pharmacies by the American Society of Health-System Pharmacists (ASHP) 9, Zellmer 10 indicated the need for manufacturers to supply pre-packed drugs in already bar coded individualized doses to increase security and save costs. This is in line with the group s studies of GS1 Brasil. Fig. 6 Ampoules with GS1 DataMatrix A considerable challenge for the national pharmaceutical industry still remains as to the application of bar code on blister packs of oral solids (Fig. 7). It is intended that, once cut (through perforated blister packs), all units have the identification required for full traceability, without re-packing need at hospitals that perform the Unit Dose dispensing process. By December 2010, other suppliers joined the programme and HIAE expanded its services to about 600 beds, emergency care and four other outpatient units (Paraisópolis, Alphaville, Perdizes- Higienópolis and Ibirapuera). About 180,000 oral solids had to be re-packaged per month and some 250,000 ampoules or vials re-labeled per month. Another 120,000 units of ampoules and vials do not have to be re-labeled anymore as they already carry the GS1 DataMatrix code. 8 Cina J, et al. Medication errors in pharmacy-based bar-code-repackaging center. Am J Health Syst Pharm 2006; 63(2): Pedersen CA, Gumpper KF. ASHP national survey on informatics: Assessment of the adoption and use of pharmacy informatics in U.S. hospitals Am J Health-Syst Pharm 2008; 65(23): Zellmer W. The current state of hospital pharmacy. Am J Health-Syst Pharm 2009; 66(10): 895. Fig. 7 Bar code on blister packs 2011/2012 GS1 Healthcare Reference Book 17

20 The traceability system of medicines at Hospital Israelita Albert Einstein in Brazil Receipt Distribution Dispensation Administration Software assessment To adopt the standards, all systems used in the hospital logistics had to be customised in order to allow the code information recovery. In the process of reading the code, the system should recognize the character FNC1, relevant Application Identifiers (AI) and save it. In the most basic example, the system must understand that specific product GTIN14 (AI 01) corresponds to a unique product in its internal inventory. It must therefore record the batch information and expiry date, and make a full identification of the medicine in the internal supply chain. Though seemingly complex, it is not. GS1 offered thorough support so that the necessary adjustments were easily understood. Bedside check medication administration The solution will also directly impact medication administration, one of the most critical and sensitive stages for error as shown in the ASHP statistics. In 2011, HIAE will adopt an electronic checking system of medication administration at bedside. In this process, the nursing staff reads the patient id code and the bar code of the medicine dispensed by the pharmacy, confirming the drug. In the absence of a bar code on the primary packaging of the product, this process becomes impractical. Much has been discussed and published about the automation of this process and the main objective is to achieve the five well-known rights: right patient, right drug, right route, right time and right dose. This particular issue has been further studied and the number 5 now comes to 9 11, where we perceive that the automated process allows most of them to be covered with the deployment of technology: electronic checking allows right patient, right drug, right dose, right time, right registration (documentation), right of refusal and right justification. Patient education and right route still remain inherent to the professional involved. 11 Elliott, M. and Liu, Y. The nine rights of medication administration: an overview. British Journal of Nursing (5), p Additional security checks According to James Reason 12, the errors are not confined to a few individuals. Even the most qualified professionals are subject to failure. Often circumstances lead to errors. The mere proposal of the use of bar code makes use of medications safer leveraging technology. Wherever possible, additional security checks during the process should be considered, The Swiss cheese model of Reason makes it very clear when failures momentarily align and potential errors become real (Fig. 8). Legislation Traceability of medicines has also entered the merit of norms of the National Agency for Sanitary Surveillance (ANVISA), the national body responsible for regulating the health sector in Brazil 13,14,15,16,17, Reason J. Human Error: Models and Management, BMJ 2000, 320: p BRASIL. Agência Nacional de Vigilância Sanitária. Consulta Pública nº 8, de 4 de março de Diário Oficial [da República Federativa do Brasil], Brasília, DF, 5 de março de 2008, Seção 1. Available at < visadoc/cp/cp%5b %5d.pdf> accessed on February 3, BRASIL. Lei nº , de 14 de janeiro de Dispõe sobre o rastreamento e do consumo de medicamentos por meio de tecnologia de captura, armazenamento e transmissão eletrônica de dados. Diário Oficial [da República Federativa do Brasil], Brasília, DF, n. 10, 15 de janeiro de 2009, Seção 1, p1. 15 BRASIL. Agência Nacional de Vigilância Sanitária. RDC Nº 59, de 24 de novembro de Dispõe sobre a implantação do Sistema Nacional de Controle de Medicamentos e definição dos mecanismos para rastreamento de medicamentos, por meio de tecnologia de captura, armazenamento e transmissão eletrônica de dados e dá outras providências. Diário Oficial [da República Federativa do Brasil], Brasília, DF, 25 de novembro de 2009, Seção 1, p BRASIL. Agência Nacional de Vigilância Sanitária. Instrução Normativa n 1, de 13 de janeiro de 2010.Regulamenta a Resolução RDC n 59, de 24 de novembro de 2009, que dispõe sobre a implantação do Sistema Nacional de Controle de Medicamentos, com vistas ao regramento da produção e o controle da distribuição das etiquetas de segurança para o Sistema de Rastreamento de Medicamentos e dá outras providências. Diário Oficial [da República Federativa do Brasil], Brasília, DF, 14 de janeiro de 2010, Seção 1, p BRASIL. Agência Nacional de Vigilância Sanitária. Instrução Normativa n 8, de 15 de junho de Dá nova redação ao caput e revoga os 1º, 2º, 3º e 4º do art. 9º da Instrução Normativa nº 1, de 13 de janeiro de 2010 [da República Federativa do Brasil], Brasília, DF, 17 de junho de 2010, Seção 1, p BRASIL. Agência Nacional de Vigilância Sanitária. Instrução Normativa n 11, de 29 de outubro de Dispõe sobre a tecnologia, a produção, o fornecimento e o controle da distribuição das etiquetas auto-adesivas de segurança para o Sistema de Rastreamento de Medicamentos e dá outras providências. [da República Federativa do Brasil], Brasília, DF, 3 de novembro de 2010, Seção 1, p /2012 GS1 Healthcare Reference Book